Biomerieux Etest PIP/TAZO/CON-4 PTC 256 Recalled for Erroneous Results
Biomerieux is recalling Etest PIP/TAZO/CON-4 PTC 256 antimicrobial susceptibility tests due to the potential for reporting false susceptible results for Piperacillin/Tazobactam.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies the agency classification as Class I, which mandates a severity score of 5 (Critical) according to the rubric.
Plain-English summary
Biomerieux is recalling 2,422 units of Etest PIP/TAZO/CON-4 PTC 256, a quantitative technique used to determine the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria. The recall is due to the potential for reporting erroneous results, specifically false susceptible results, for Piperacillin/Tazobactam.
The affected product is identified by Reference 521458 and includes specific lot numbers: 1004397280, 1004271100, 1003977350, 1003903650, 1003561810, 1003239850, 1002489700, 1002273480, 1002216620, and 1002120370. The product was distributed worldwide, including nationwide in the United States and in numerous international countries.
Healthcare facilities and laboratories should stop using the affected lots and contact Biomerieux for instructions on returning the product. This recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
- Manufacturer
- Biomerieux
- Affected units
- 2,422
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Ref. 521458
- Lot numbers: 1004397280
- 1004271100
- 1003977350
- 1003903650
- 1003561810
- 1003239850
- 1002489700
- 1002273480
- 1002216620 and 1002120370.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Biomerieux under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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See all →- ModerateBiomerieux Recalls Etest Piperacillin/Tazobactam Tests Due to False Results
FDA (Devices) · 2015-12-30
- HighBiomerieux Recalls Etest PIP/TAZO/CON-4 PTC 256 Antimicrobial Susceptibility Tests
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